Associate Director, Immunoassay Critical Reagents and Reference Materials

Associate Director, Immunoassay Critical Reagents and Reference Materials

Vaxcyte is seeking an accomplished Associate Director, Immunoassay Critical Reagents and Reference Materials to join the Global Analytical Development organization. This role will provide scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials that support immunoassays across Vaxcyte's vaccine pipeline.

This is an onsite, laboratory-based scientific leadership position requiring active engagement in laboratory operations, study oversight, inventory management, data review, and technical decision-making. The successful candidate will bring deep expertise in antibody generation and characterization, reagent qualification, reference standard development, customized assay material management, stability assessment, and lifecycle strategy.

A key focus of this role will be establishing and maintaining robust reagent and reference material systems that ensure long-term supply continuity, analytical reliability, and regulatory readiness. The individual will support immunoassay platform advancement and enable fit-for-purpose assays throughout development, validation, commercialization, and lifecycle management.

The Associate Director will collaborate closely with cross-functional teams, including Analytical Development, Quality, Manufacturing, Regulatory Affairs, and Supply Chain, as well as external partners such as CROs, CDMOs, contract testing laboratories, reagent suppliers, and technology providers. This role is responsible for ensuring the consistent availability, performance, documentation, and oversight of critical immunoassay materials while driving continuous improvement and operational excellence across the portfolio.

Essential functions include:

• Contribute to the establishment and growth of the Immunoassay Development Capability within Global Analytical Development organization, with primary responsibility for immunoassay critical reagents, reference materials, customized assay materials, stability programs, and associated lifecycle management systems.
• Engage daily in laboratory operations, including reagent planning, reference material planning, sample and material readiness, laboratory study coordination, inventory review, data review, documentation, and hands-on technical support.
• Lead the generation, characterization, qualification, stability planning, lifecycle management, and inventory control of antibody reagents used in immunoassays, including capture antibodies, detection antibodies, monoclonal antibodies, polyclonal antibodies, labeled antibodies, and other assay-specific binding reagents.
• Support antibody reagent generation strategies, including antigen design, immunization strategy, hybridoma or recombinant antibody generation, screening, clone selection, purification, conjugation, labeling, characterization, and long-term supply planning.
• Develop and execute antibody characterization plans, including specificity, affinity, cross-reactivity, epitope behavior, lot-to-lot comparability, assay performance attributes, stability, and suitability for intended immunoassay use.
• Lead the generation, characterization, qualification, bridging, stability planning, lifecycle management, and inventory control of reference materials, including reference standards, assay controls, calibrators, system suitability controls, bridging controls, and other assay performance control materials.
• Design and execute critical reagent and reference material stability studies, including protocol development, storage condition assessment, timepoint planning, testing strategy, acceptance criteria, data interpretation, trend evaluation, expiry or retest dating recommendations, and stability report generation.
• Lead the generation, characterization, qualification, and lifecycle management of customized immunoassay critical materials, including MSD plates, coated plates, Sulfo-TAG or other labeled detection reagents, Luminex beads, bead-conjugated reagents, multiplex assay components, customized assay kits, buffers, blocking reagents,…